PARP Inhibitor Approved for BRCA-Mutated mCRPC

FDA has approved rucaparib for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer in men previously treated with androgen-receptor directed therapy and taxane-based chemotherapy.

Rucaparib (Rubraca, Clovis Oncology, Inc.), a PARP
inhibitor, on May 15 received accelerated approval from FDA for use in men with
metastatic castration-resistant prostate cancer (mCRPC) associated with a
deleterious BRCA mutation.

The approval is based on findings from TRITON2, an
ongoing multicenter, single-arm clinical trial that enrolled 115 patients with BRCA-mutated mCRPC previously treated
with androgen-receptor directed therapy and taxane-based chemotherapy.

Investigators assessed objective response rate (ORR) and
duration of response (DOR) in 62 patients with measurable disease. The
confirmed ORR was 44%. The median DOR was not evaluable, but the range 1.7 to 24
or more months. Fifteen of the 27 (56%) patients with confirmed objective
responses had a DOR of at least 6 months.

The most common adverse reactions (occurring
in 20% or more of patients) among all 115 patients with BRCA-mutated mCRPC were fatigue, nausea,
anemia, increased ALT/AST, decreased appetite, rash, constipation,
thrombocytopenia, vomiting, and diarrhea, FDA said in a press release.

Related Articles

The recommended rucaparib dose is 600 mg orally twice daily with or without food. Patients receiving rucaparib for mCRPC should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy, according to the FDA.

Want to read more?

CancerTherapyAdvisor.com is a free online resource that offers oncology healthcare professionals a comprehensive knowledge base of practical oncology information and clinical tools to assist in making the right decisions for their patients.

Our mission is to provide practice-focused clinical and drug information that is reflective of current and emerging principles of care that will help to inform oncology decisions.